10 June 2010, Avita Medical Ltd (ASX: AVH): In an important milestone for Avita Medical the first United States-based treatment of a patient with ReCell® under the approved FDA protocol was conducted. The treatment of a burns victim on 27 May 2010 was at Wake Forest University Baptist Medical Burn Center in Winston-Salem, North Carolina.
The patient presented with burns on both arms; burn sites were arbitrarily labelled “A” and “B” per protocol. Through the protocol’s blinded randomisation process one site was assigned treatment with ReCell®, the other served as a control and was treated with split thickness skin graft, the current standard of care.
On seven-day follow-up the patient had excellent results: the ReCell® graft site had 100% take and was fully re-epithelialised (i.e., the treated wound was completely covered with new skin with no open areas or blisters). In contrast, the control site had 75-80% take with 20-25% of the area having unhealed open interstices. Similarly, the ReCell® donor site was 100% closed and fully re-epithelialised whereas the control traditional graft donor site on the thigh remained open and slightly oozy with numerous bleeding spots. Critically, in self-reporting of pain, the patient reported 0/10 pain at the ReCell® site and 10/10 pain at the traditional control site.
“We are very pleased but not surprised by the excellent outcome,” said Dr William Dolphin, CEO Avita Medical. “The ReCell® Spray-On-Skin technology offers great benefits to the patient and clinicians and has the potential to deliver significant cost savings to the healthcare system.”
Under the revised and approved FDA protocol ReCell® Spray-On-Skin and the AFIRM defense forces sponsored study has attracted national and international attention. Television network CNN filmed the procedure for an upcoming production describing new frontier products in regenerative medicine and will continue to follow patients treated with ReCell®.
Subsequent to FDA trial approval in December 2009, Avita has worked with each of the participating investigational sites to obtain Institutional Review Board (IRB) approval for the conduct of the study. This has occurred on a site-by-site basis and involves a separate IRB submission for each site.
Each institute’s IRB ethics committee for research involving human subjects typically meets on a monthly or 6-weekly basis and must review and approve the research protocol, all patient consent forms and ensure proper patient safety. They must also ensure that the study complies with all regulatory requirements.
Once IRB approval was achieved, Avita Medical entered into negotiations with the business unit at each institute and negotiated final contractual terms including institutional overheads, facility fees and payment structure. Enrolment cannot commence until IRB approval and contracts with each institute business office are signed.
In parallel to the above all necessary patient consent and data collection forms were designed and printed, material supplies for the study organised and data bases built and tested to accommodate input, review, retrieval and archiving of photographic and numeric data. None of this could be done until after FDA protocol approval was granted.
“It is a long process and can be quite frustrating,” said Dr William Dolphin, CEO of Avita Medical. “Because the field of regenerative medicine and cell-based therapies is so new, the FDA and ethical review boards are conservative in their approvals. This translates to longer lead times. None-theless, the entire process has now been completed at five key investigational sites and we have achieved the substantial US milestone of commenced enrolment and application of ReCell®.”
ABOUT AVITA MEDICAL LIMITED
Avita Medical Limited (www.avitamedical.com) is a publicly listed, global medical technology company that develops and distributes regenerative and tissue-engineered products for the treatment of a wide range of wounds, scars and skin defects. Using proprietary tissue-culture/collection technology, the company is able to provide innovative treatment solutions derived from the patient’s own skin to enhance healing rates, reduce scar formation and reintroduce pigmentation into the skin.
ReCell® is a stand-alone, rapid cell harvesting device that enables surgeons to treat skin defects using the patient’s own cells. The surgeon can prepare a small quantity of cells within 30 minutes on site, replacing the need for skin grafts and obviating the requirement for culturing laboratories. ReCell® has been designed for use in a wide variety of burns, plastic, reconstructive and cosmetic procedures.
ReCell® is patented, CE marked for the EU and TGA registered in Australia.
